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Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.

Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.

The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.

A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.

The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.

Horizontal-Vertical Lumbar Valve Systems: The Horizontal-Vertical Lumbar Valve System is an implantable device that provides controlled intraventricular pressure and cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. The system minimizes overdrainage by automatically compensating for changes in CSF hydrostatic pressure when the patient changes from a recumbent to an upright position.

Spetzler Lumbar Peritoneal Shunt Systems: The Spetzler Lumbar Peritoneal Shunt Systems are designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. The lumbar catheter is inserted into the lumbar subarachnoid space through a 8.89cm (3½-inch), 14- gauge Tuohy spinal needle with a Huber tip. A catheter passer and peritoneal trocar may be used to bring the peritoneal catheter section around the flank and into the peritoneal cavity.

A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired.

This document is a 510(k) premarket notification for the Integra LifeSciences Corporation's Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems. It claims substantial equivalence to previously marketed predicate devices (K101381 and K152897). The primary change in this submission is an update to the MRI safety information in the labeling.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it claims substantial equivalence to predicate devices. The "performance" assessment is based on the devices having "Same" performance specifications as the predicate, which means they meet the established performance of the legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "No additional non-clinical testing was performed for this submission."
The testing referenced was performed to support the initial MRI Labeling for Integra Shunts and Implanted Accessories (K101381) and subsequent updates (K152897). The details of the sample size for these tests, country of origin, or whether they were retrospective or prospective are not provided in this document.

The tests listed were:

• Magnetically Induced Displacement Force and Torque Test
• RF Heating Test
• Image Artifact Test
• Pressure Flow Test

These are all non-clinical (bench) tests, not clinical studies involving patient data. Therefore, concepts like "test set sample size" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable directly to this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical (bench) testing, not studies that require expert-established ground truth from clinical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical (bench) testing, not studies that require adjudication of clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device described is a physical implantable medical device (CSF shunt system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests mentioned (Magnetically Induced Displacement Force and Torque Test, RF Heating Test, Image Artifact Test, and Pressure Flow Test), the "ground truth" would be established by engineering standards, physical measurements, and calculations according to relevant ASTM standards (e.g., ASTM F2052-15 mentioned for MRI safety calculations). It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device and does not involve machine learning or AI models that require a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical medical device and does not involve machine learning or AI models that require a training set.

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